COSYNTROPIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COSYNTROPIN (COSYNTROPIN).
Synthetic adrenocorticotropic hormone (ACTH) analog that stimulates adrenal cortex to secrete cortisol, corticosterone, and androgens.
| Metabolism | Primarily hepatic and renal metabolism via proteolytic degradation. |
| Excretion | Primarily renal; >90% of dose excreted unchanged in urine; negligible biliary/fecal elimination. |
| Half-life | Terminal elimination half-life is approximately 15 minutes; rapid clearance requires continuous infusion or frequent dosing for sustained effect. |
| Protein binding | Low (~1-3%); weakly bound to albumin and alpha-globulins. |
| Volume of Distribution | Approximately 0.4 L/kg; distributes mainly in extracellular fluid; does not extensively penetrate tissues. |
| Bioavailability | IM/IV: 100% (parenteral only); not available orally due to rapid enzymatic degradation in GI tract. |
| Onset of Action | IV/IM: 15-30 minutes; plasma cortisol levels peak at 30-60 minutes post-dose. |
| Duration of Action | 2-4 hours following a single dose; clinical effect (cortisol stimulation) wanes as drug is cleared; used for short diagnostic testing. |
250 mcg to 2500 mcg intramuscularly or intravenously, with 250 mcg being the most commonly used dose for cosyntropin stimulation test; frequency as needed per test protocol.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; hemodialysis does not affect dosing. |
| Liver impairment | No dose adjustment required for hepatic impairment; Child-Pugh classification does not necessitate modification. |
| Pediatric use | Children >2 years: 125 mcg intravenously or intramuscularly; Infants/children ≤2 years: 125 mcg intravenously or intramuscularly; Neonates: 15 mcg/kg intravenously or intramuscularly. |
| Geriatric use | No specific geriatric dose adjustment; use lowest effective dose and monitor for adverse effects due to potential renal or hepatic age-related changes; standard adult dosing with caution. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COSYNTROPIN (COSYNTROPIN).
| Breastfeeding | Cosyntropin is unlikely to appear in breast milk due to rapid degradation. M/P ratio unknown. Caution with high doses due to potential effects on infant cortisol. |
| Teratogenic Risk | Cosyntropin is a synthetic ACTH analog. In animals, corticosteroids are teratogenic. Human data: insufficient. Avoid in first trimester unless benefit outweighs risk. Second/third trimester: possible adrenal suppression in neonate if used long-term. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warning exists for cosyntropin.
| Serious Effects |
["Hypersensitivity to cosyntropin or any component","Uncontrolled infections","Recent vaccination with live vaccines"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis may occur","May suppress endogenous ACTH production with prolonged use","May exacerbate pre-existing infections due to immunosuppression","Caution in patients with osteoporosis, diabetes, or psychosis","May cause electrolyte disturbances (e.g., hypokalemia, sodium retention)"] |
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| Monitor maternal blood pressure, blood glucose, serum potassium, and signs of infection. Fetal monitoring not routinely required; long-term use may warrant assessment of fetal growth. |
| Fertility Effects | No specific data on fertility effects. Corticosteroids may alter hormonal balance and affect ovulation; theoretical risk of menstrual irregularities. |